Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
This recall has been terminated (originally issued September 20, 2008).
- Company
- Integra Lifesciences Corp.
- Recall Initiated
- July 2, 2008
- Posted
- September 20, 2008
- Terminated
- September 22, 2008
- Recall Number
- Z-2328-2008
- Quantity
- 10 units
- Firm Location
- Plainsboro, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
Distribution
Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
Lot / Code Info
Catalog Number 38101, Lot Number 105BA0121823
Root Cause
Labeling mix-ups
Action Taken
The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.